GAL-PUT CONTROLS, NORMAL&DEFICIENT

GAL-PUT CONTROLS, NORMAL&DEFICIENT is an FDA 510(k)-cleared medical device (K800910) manufactured by Sigma Chemical Co.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 28, 1980. Regulation: 8.